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The vast majority of drug recalls in the past 10 years have been triggered by cardiovascular safety issues, which must be managed by doing a thorough QT study (TQTS) early in the clinical trial of any new compound, according to Daniel Goodman, director of medical affairs for Covance Cardiac Safety Services.
The increasingly difficult challenge of patient recruitment can be tackled successfully if sponsors adopt the right strategies from the start, say experts in the field.
Merck announced Aug. 17 that it will soon start allowing HIV/AIDS patients who are out of other options to take an experimental new drug it is developing.
Data monitoring committees (DMCs) are required in increasing numbers of clinical trials, but it is important to know when they are needed and to delineate their responsibilities carefully so as not to "create a monster," according to an expert speaking at a recent FDAnews audioconference.